Peripherally Inserted Central Catheter Versus Centrally Inserted Central Catheter for In-Hospital Infusion Therapy: A Cost-Effectiveness Analysis.

OBJECTIVES: To evaluate the comparative effectiveness and cost-effectiveness of peripherally inserted central catheters (PICCs) compared with centrally inserted central catheters (CICCs). METHODS: Prospective cohort study was followed by an economic analysis over a 30-day time horizon. Propensity score matching was used to select hospitalized adults with similar indications for PICC or CICC. The composite outcome was device removal or replacement because of complications before the end of treatment. The economic evaluation was based on a decision tree model for cost-effectiveness analysis, with calculation of the incremental cost-effectiveness ratio (ICER) per catheter removal avoided. All costs are presented in Brazilian reais (BRL) (1 BRL = 0.1870 US dollar). RESULTS: A total of 217 patients were followed in each group; 172 (79.3%) of those receiving a PICC and 135 (62.2%) of those receiving a CICC had no device-related complication, respectively. When comparing the events leading to device removal, the risk of composite endpoint was significantly higher in the CICC group (hazard ratio 0.20; 95% CI 0.11-0.35). The cost of PICC placement was BRL 1290.98 versus BRL 467.16 for a CICC. In the base case, the ICER for placing a PICC instead of a CICC was BRL 3349.91 per removal or replacement avoided. On univariate sensitivity analyses, the model proved to be robust within an ICER range of 2500.00 to 4800.00 BRL. CONCLUSIONS: PICC placement was associated with a lower risk of complications than CICC placement. Although the cost of a PICC is higher, its use avoided complications and need for catheter replacement before the end of treatment.

Multifaceted Strategy Based on Automated Text Messaging After a Recent Heart Failure Admission: The MESSAGE-HF Randomized Clinical Trial.

Importance: Readmissions after an index heart failure (HF) hospitalization are a major contemporary health care problem. Objective: To evaluate the feasibility and efficacy of an intensive telemonitoring strategy in the vulnerable period after an HF hospitalization. Design, Setting, and Participants: This randomized clinical trial was conducted in 30 HF clinics in Brazil. Patients with left ventricular ejection fraction less than 40% and access to mobile phones were enrolled up to 30 days after an HF admission. Data were collected from July 2019 to July 2022. Intervention: Participants were randomly assigned to a telemonitoring strategy or standard care. The telemonitoring group received 4 daily short message service text messages to optimize self-care, active engagement, and early intervention. Red flags based on feedback messages triggered automatic diuretic adjustment and/or a telephone call from the health care team. Main Outcomes and Measures: The primary end point was change in N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to 180 days. A hierarchical win-ratio analysis incorporating blindly adjudicated clinical events (cardiovascular deaths and HF hospitalization) and variation in NT-proBNP was also performed. Results: Of 699 included patients, 460 (65.8%) were male, and the mean (SD) age was 61.2 (14.5) years. A total of 352 patients were randomly assigned to the telemonitoring strategy and 347 to standard care. Satisfaction with the telemonitoring strategy was excellent (net promoting score at 180 days, 78.5). HF self-care increased significantly in the telemonitoring group compared with the standard care group (score difference at 30 days, -2.21; 95% CI, -3.67 to -0.74; P = .001; score difference at 180 days, -2.08; 95% CI, -3.59 to -0.57; P = .004). Variation of NT-proBNP was similar in the telemonitoring group compared with the standard care group (telemonitoring: baseline, 2593 pg/mL; 95% CI, 2314-2923; 180 days, 1313 pg/mL; 95% CI, 1117-1543; standard care: baseline, 2396 pg/mL; 95% CI, 2122-2721; 180 days, 1319 pg/mL; 95% CI, 1114-1564; ratio of change, 0.92; 95% CI, 0.77-1.11; P = .39). Hierarchical analysis of the composite outcome demonstrated a similar number of wins in both groups (telemonitoring, 49 883 of 122 144 comparisons [40.8%]; standard care, 48 034 of 122 144 comparisons [39.3%]; win ratio, 1.04; 95% CI, 0.86-1.26). Conclusions and Relevance: An intensive telemonitoring strategy applied in the vulnerable period after an HF admission was feasible, well-accepted, and increased scores of HF self-care but did not translate to reductions in NT-proBNP levels nor improvement in a composite hierarchical clinical outcome. Trial Registration: ClinicalTrials.gov Identifier: NCT04062461.

Multifaceted strategy based on automated text messaging after a recent heart failure admission: the MESSAGE-HF Randomized Clinical Trial

IMPORTANCE: Readmissions after an index heart failure (HF) hospitalization are a major contemporary health care problem. OBJECTIVE: To evaluate the feasibility and efficacy of an intensive telemonitoring strategy in the vulnerable period after an HF hospitalization. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial was conducted in 30 HF clinics in Brazil. Patients with left ventricular ejection fraction less than 40% and access to mobile phones were enrolled up to 30 days after an HF admission. Data were collected from July 2019 to July 2022. INTERVENTION: Participants were randomly assigned to a telemonitoring strategy or standard care. The telemonitoring group received 4 daily short message service text messages to optimize self-care, active engagement, and early intervention. Red flags based on feedback messages triggered automatic diuretic adjustment and/or a telephone call from the health care team. MAIN OUTCOMES AND MEASURES: The primary end point was change in N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to 180 days. A hierarchical win-ratio analysis incorporating blindly adjudicated clinical events (cardiovascular deaths and HF hospitalization) and variation in NT-proBNP was also performed. RESULTS: Of 699 included patients, 460 (65.8%) were male, and the mean (SD) age was 61.2 (14.5) years. A total of 352 patients were randomly assigned to the telemonitoring strategy and 347 to standard care. Satisfaction with the telemonitoring strategy was excellent (net promoting score at 180 days, 78.5). HF self-care increased significantly in the telemonitoring group compared with the standard care group (score difference at 30 days, -2.21; 95% CI, -3.67 to -0.74; P = .001; score difference at 180 days, -2.08; 95% CI, -3.59 to -0.57; P = .004). Variation of NT-proBNP was similar in the telemonitoring group compared with the standard care group (telemonitoring: baseline, 2593 pg/mL; 95% CI, 2314-2923; 180 days, 1313 pg/mL; 95% CI, 1117-1543; standard care: baseline, 2396 pg/mL; 95% CI, 2122-2721; 180 days, 1319 pg/mL; 95% CI, 1114-1564; ratio of change, 0.92; 95% CI, 0.77-1.11; P = .39). Hierarchical analysis of the composite outcome demonstrated a similar number of wins in both groups (telemonitoring, 49 883 of 122 144 comparisons [40.8%]; standard care, 48 034 of 122 144 comparisons [39.3%]; win ratio, 1.04; 95% CI, 0.86-1.26). CONCLUSIONS and relevance: An intensive telemonitoring strategy applied in the vulnerable period after an HF admission was feasible, well-accepted, and increased scores of HF self-care but did not translate to reductions in NT-proBNP levels nor improvement in a composite hierarchical clinical outcome.

Perceived dyspnea and experience of hospitalized patients with acute decompensated heart failure undergoing an early MObilization protocol with immersive Virtual rEality: MOVE study protocol for a parallel superiority randomized clinical trial.

BACKGROUND: Immersive virtual reality (VR) is an innovative strategy for inpatient rehabilitation programs. Using immersive VR in early mobilization protocols has not yet been investigated in the setting of hospitalized patients with acute decompensated heart failure (ADHF), especially to improve perceived dyspnea, a common symptom of heart failure (HF). METHODS: This is a single-center parallel superiority randomized clinical trial. The study will be conducted at a public teaching hospital in Brazil from January 2023 to January 2024. The sample will include adult patients with ADHF hospitalized for at least 24 h, randomly assigned in a 1:1 ratio to the control (standard early mobilization protocol conducted in the intensive care unit (ICU)) or intervention group (the same standard early mobilization protocol but associated with immersive VR). The primary outcome will be assessing perceived dyspnea, and the secondary outcome will be assessing patient experience. DISCUSSION: Using immersive VR in early mobilization protocols in the ICU is expected to improve perceived dyspnea in patients with ADHF as well as patient experience regarding care. This study has the potential to increase patient adherence to early mobilization protocols in the setting of ADHF as well as to promote a positive patient experience. Filling this gap could promote the rational incorporation of technologies in health care. TRIAL REGISTRATION: This study protocol is in its first version. CLINICALTRIALS: gov NCT05596292. Registered on 1 December 2022.

Specific causal validation of nursing diagnosis Risk for thrombosis: A case-control study.

PURPOSE: This study aims to perform specific causal validation of nursing diagnosis Risk for thrombosis (00291) of the NANDA International (NANDA-I) classification. METHODS: This is a case-control study conducted in a university hospital from January to October 2020. A total of 516 adult patients were included-344 in the Case Group (with venous or arterial thrombosis evidenced by imaging) and 172 in the Control Group (without thrombosis). Statistical analysis was performed by univariate and multivariate logistic regression test, and odds ratios were calculated to measure the effect of exposure between groups. The study was approved by the Research Ethics Committee. FINDINGS: The patients were predominantly female and aged 59 ± 16 years. In the univariate logistic analysis, five risk factors were significantly associated with thrombosis, two at-risk populations and 12 associated conditions. In the multivariate regression model, the following risk factors remained independently associated (p < 0.05): inadequate knowledge of modifiable factors (OR: 3.03; 95% CI: 1.25-8.56) and ineffective medication self-management (OR: 3.2; 95% CI:1.77-6.26); at-risk populations with history (OR: 2.16; 95% CI: 1.29-3.66) and family history of thrombosis (OR:2.60; 95% CI: 1.03-7.49); and the conditions associated with vascular diseases (OR:6.12; 95% CI:1.69-39.42), blood coagulation disorders (OR: 5.14; 95% CI:1.85-18.37), atherosclerosis (OR:2.07; 95% CI: 1.32-3.27), critical illness (OR: 2.28; 95% CI: 1.42-3.70), and immobility (OR: 2.09; 95% CI: 1.10-4.12). CONCLUSIONS: The clinical validation allowed to establish strong evidence for the refinement of the diagnosis Risk for thrombosis and, consequently, to raise its level of evidence in the classification of NANDA-I. IMPLICATIONS FOR NURSING PRACTICE: The evidence pointed out by this study favors the establishment of thrombosis diagnosis in an accurate way by nurses in clinical practice, directing preventive interventions to patients in this risk condition.

OBJETIVO: Realizar a validação causal específica do diagnóstico de enfermagem Risco de trombose (00291) da classificação diagnóstica da NANDA International, Inc. MÉTODOS: Estudo de caso-controle, realizado em hospital universitário entre janeiro e outubro de 2020. Foram incluídos 516 pacientes adultos - 344 no Grupo Caso (com trombose venosa ou arterial evidenciada em exame de imagem) e 172 no Grupo Controle (sem trombose). A análise estatística ocorreu por teste de regressão logística univariada e multivariada, e Odds ratios calculados para medir o efeito da exposição entre os grupos. O estudo foi aprovado em Comitê de Ética. RESULTADOS: Os pacientes foram predominantemente do sexo feminino e idade de 59±16 anos. Na análise logística univariada foi associado significativamente á trombose: cinco fatores de risco, duas populações em risco e 12 condições associadas. No modelo de regressão multivariada permaneceram independentemente associados (P<0,05) os fatores de risco conhecimento inadequado sobre os fatores modificáveis (OR:3,03; IC95%:1,25-8,56) e autogestão ineficaz de medicamentos (OR:3,24; IC95%:1,77-6,26); as populações em risco com história prévia (OR:2,16; IC95%:1,29-3,66) e história familiar de trombose (OR:2,60; IC95%:1,03-7,49); e as condições associadas a doenças vasculares (OR:6,12; IC95%:1,69-39,42), distúrbios de coagulaçõo (OR:5,14; IC95%:1,85-18,37),aterosclerose (OR:2,07; IC95%:1,32-3,27), doença crítica (OR:2,28; IC95%:1,42-3,70) e imobilidade (OR:2,09; IC95%:1,10-4,12). CONCLUSÕES: A validação clínica permitiu estabelecer fortes evidências para o refinamento do diagnóstico Risco de trombose e, consequentemente, elevar seu nível de evidência na classificação da NANDA-I. IMPLICAÇÕES PARA A PRÁTICA: As evidências apontadas pelo estudo favorecem o estabelecimento deste diagnóstico de forma acurada pelos enfermeiros na prática clínica, direcionando intervenções preventivas aos pacientes nesta condiçõo de risco.

Use of the ADHERE Risk Model as a Predictor of Risk of in-Hospital Worsening Heart Failure in a Cohort. / Uso do Modelo de Risco ADHERE como Preditor de Piora Intra-Hospitalar de Insuficiência Cardíaca em uma Coorte.

BACKGROUND: Patients admitted with acute decompensated heart failure (HF) are subject to developing worsening episodes that require more complex interventions. The Acute Decompensated Heart Failure National Registry (ADHERE) risk model was developed in the United States to predict the risk of in-hospital worsening HF. OBJECTIVE: To use the ADHERE risk model in the assessment of risk of in-hospital worsening HF and to determine its sensitivity and specificity in hospitalized patients. METHODS: This cohort study was conducted at a Brazilian public university hospital, and data from 2013 to 2020 were retrospectively collected. P values < 0.05 were considered statistically significant. RESULTS: A total of 890 patients with a mean age of 74 ± 8 years were included. The model showed that, in the group of 490 patients at risk, 254 (51.8%) developed in-hospital worsening HF. In the group of 400 patients not at risk, only 109 (27.2%) experienced worsening HF. The results demonstrated a statistically significant curve (area under the curve = 0.665; standard error = 0.018; P < 0.01; confidence interval = 0.609 to 0.701), indicating good accuracy. The model had a sensitivity of 69.9% and a specificity of 55.2%, with a positive predictive value of 52% and a negative predictive value of 72.7%. CONCLUSIONS: In this cohort, we showed that the ADHERE risk model was able to discriminate patients who in fact developed worsening HF during the admission period, from those who did not.

FUNDAMENTO: Pacientes hospitalizados com insuficiência cardíaca (IC) aguda descompensada estão sujeitos a desenvolver episódios de piora que requerem intervenções mais complexas. O modelo de predição de risco "Acute Decompensated Heart Failure National Registry" (ADHERE) foi desenvolvido nos Estados Unidos para prever o risco de piora intra-hospitalar da IC. OBJETIVO: Utilizar o modelo de predição de risco ADHERE para avaliar o risco de piora intra-hospitalar da IC e determinar a sua sensibilidade e especificidade em pacientes hospitalizados. MÉTODOS: O presente estudo de coorte foi realizado em um hospital universitário público brasileiro e os dados de 2013 a 2020 foram coletados retrospectivamente. Foram considerados estatisticamente significativos valores de p < 0,05. RESULTADOS: Foram incluídos 890 pacientes com idade média de 74 ± 8 anos. O modelo mostrou que no grupo de 490 pacientes de risco, 254 (51,8%) desenvolveram piora intra-hospitalar da IC. No grupo de 400 pacientes sem risco, apenas 109 (27,2%) apresentaram piora da IC. Os resultados demonstraram uma curva estatisticamente significativa (área sob a curva = 0,665; erro padrão = 0,018; p < 0,01; intervalo de confiança = 0,609 a 0,701), indicando boa precisão. O modelo apresentou sensibilidade de 69,9% e especificidade de 55,2%, com valor preditivo positivo de 52% e valor preditivo negativo de 72,7%. CONCLUSÕES: Na presente coorte, demonstramos que o modelo de predição de risco ADHERE foi capaz de discriminar pacientes que, de fato, desenvolveram piora da IC durante o período de internação daqueles que não desenvolveram.

Biomarkers Associated with Thrombosis in Patients with Peripherally Inserted Central Catheter: A Systematic Review and Meta-Analysis.

BACKGROUND: The measurement and identification of plasma biomarkers can support the estimation of risk and diagnosis of deep vein thrombosis (DVT) associated with the use of a peripherally inserted central catheter (PICC). OBJECTIVES: This systematic review and meta-analysis aimed to identify the association between the levels of potential biomarkers that reflect the activation of the blood system, long-term vascular complications, inflammatory system, and the occurrence of PICC-related DVT. METHODS: Seven electronic databases (Embase, Web of Science, Medline, Scopus, Cinahl, Cochrane Central Register of Controlled Trials, and ERIC) were searched to identify literature published until December 2022. Studies were required to report: (I) adult and pediatric patients, outpatient or admitted to clinical, surgical, or ICU with PICC; (II) patients with PICC-related DVT and patients without PICC-related DVT as a comparator; and (III) at least one biomarker available. The Newcastle-Ottawa Scale was used to evaluate the quality of the studies. Study precision was evaluated by using a funnel plot for platelets level. We provided a narrative synthesis and meta-analysis of the findings on the biomarkers' outcomes of the studies. We pooled the results using random effects meta-analysis. The meta-analysis was conducted using Review Manager software v5.4. This systematic review is registered in PROSPERO (CRD42018108871). RESULTS: Of the 3564 studies identified (after duplication removal), 28 were included. PICC-related DVT was associated with higher D-dimers (0.37 µg/mL, 95% CI 0.02, 0.72; p = 0.04, I2 = 92%; p for heterogeneity < 0.00001) and with higher platelets (8.76 × 109/L, 95% CI 1.62, 15.91; p = 0.02, I2 = 41%; p for heterogeneity = 0.06). CONCLUSIONS: High levels of D-dimer and platelet were associated with DVT in patients with PICC. However, biomarkers such as APTT, fibrinogen, FDP, glucose, hemoglobin, glycated hemoglobin, INR, prothrombin time, prothrombin fragment 1.2, the thrombin-antithrombin complex, and WBC were not related to the development of DVT associated with PICC.

UltraSound guided PEripheral Catheterization increases first-atTempt success RAte in hospitalized patients when compared with conventional technique: SPECTRA - Randomized Clinical Trial.

BACKGROUND: Peripheral intravenous catheter (PIVC) insertion is the most common invasive procedure in the hospital setting. Ultrasound guided PIVC insertion in specific populations and settings has shown patient care benefits. OBJECTIVE: To compare the success rate of first attempts of ultrasound guided PIVC insertion performed by nurse specialists with conventional PIVC insertion performed by nurse assistants. METHOD: Randomized, controlled, single-center clinical trial registered on the ClinicalTrials.gov platform under registration NTC04853264, conducted at a public university hospital from June to September 2021. Adult patients hospitalized in clinical inpatient units with an indication for intravenous therapy compatible with a peripheral venous network were included. Participants in the intervention group (IG) received ultrasound guided PIVC performed by nurse specialists from the vascular access team, while those in the control group (CG) received conventional PIVC by nurse assistants. RESULTS: The study included a total of 166 patients: IG (n = 82) and CG (n = 84), mean age 59.5 ± 16.5 years, mostly women (n = 104, 62.7%) and white (n = 136, 81.9%). Success rate on the first attempt of PIVC insertion in IG was 90.2% and in CG was 35.7% (p < 0.001), with a relative risk of 2.5 (95% CI 1.88-3.40) for success in IG versus CG. Overall assertiveness rate was 100% in IG and 71.4% in CG. Regarding procedure performance time, the medians in IG and CG were 5 (4-7) and 10 (6-27.5) min respectively (p < 0.001). As for the incidence of negative composite outcomes, IG had lower rates compared to CG, 39% versus 66.7% (p < 0.001), generating a 42% lower probability of negative outcomes in IG, 0.58 (95% CI: 0.43-0.80). CONCLUSION(S): Successful first-try insertion was higher in the group receiving ultrasound-guided PIVC. Moreover, there were no insertion failures and IG presented lower insertion time rates and incidence of unfavorable outcomes.

Hemostasis control after femoral percutaneous approach: A systematic review and meta-analysis.

BACKGROUND: Hemostasis control after percutaneous endovascular procedures through the femoral approach remains challenging for catheterization laboratory nurses, given method variability. OBJECTIVE: To summarize the available evidence on vascular devices efficacy dedicated to hemostasis control compared to the extrinsic compression after percutaneous procedures in the femoral vein or artery. METHODS: A systematic review with meta-analysis of randomized clinical trials was conducted. We compared different hemostasis methods in adult patients who underwent diagnostic and/or therapeutic procedures through femoral access. The databases searched were PubMed, Embase, CINAHL and Cochrane CENTRAL, and updated on 03/2022. The outcomes included hematoma, pseudoaneurysm, bleeding, minor and major vascular complication, time to hemostasis, device failure, and manual compression repetition. The risk of bias was assessed using the Cochrane Risk of Bias Tool 1.0. Pooled effect sizes on continuous, categorical and proportion variables were estimated with the random effects model. The continuous variables were summarized as the difference between means weighted by the inverse of variance (WMD), and the categorical ones by the summary of relative risks (RR), estimated by the DerSimonian and Laird method. The Freeman-Tukey method was used to estimate the summary effect of proportions. RESULTS: Fifty articles were included in the systematic review. When compared to extrinsic compression, vascular closure devices resulted in a relative risk reduction (RRR) for hematoma: RR 0.82 [95%CI 0.72 to 0.94] and in shorter time to hemostasis WMD -15.06 min [95%CI -17.56 to -12.56]; no association was observed between interventions with vascular closure devices and extrinsic compression for pseudoaneurysm, bleeding, minor and major vascular complications. Compared to extrinsic compression, sealant or gel type devices were compatible with a RRR for hematoma: RR 0.73 [95%CI 0.59 to 0.90]; and metal clip or staple type devices for pseudoaneurysm: RR 0.48 [95%CI 0.25 to 0.90]; and major vascular complication: RR 0.33 [95%CI 0.17 to 0.64]. For each 100 observations, the device failure rate for metal clip or staple was 3.28% [95%CI 1.69 to 6.27]; for suture 6.84% [95%CI 4.93 to 9.41]; for collagen 3.15% [95%CI 2.24 to 4.41]; and for sealant or gel 7.22% [95% CI 5.49 to 9.45]. CONCLUSIONS: Vascular closure devices performed better in hemostasis control. The certainty of the evidence was rated as very low to moderate. REGISTRATION: PROSPERO CRD42019140794.

Uso do Modelo de Risco ADHERE como Preditor de Piora Intra-Hospitalar de Insuficiência Cardíaca em uma Coorte / Use of the ADHERE Risk Model as a Predictor of Risk of in-Hospital Worsening Heart Failure in a Cohort

Resumo Fundamento Pacientes hospitalizados com insuficiência cardíaca (IC) aguda descompensada estão sujeitos a desenvolver episódios de piora que requerem intervenções mais complexas. O modelo de predição de risco "Acute Decompensated Heart Failure National Registry" (ADHERE) foi desenvolvido nos Estados Unidos para prever o risco de piora intra-hospitalar da IC. Objetivo Utilizar o modelo de predição de risco ADHERE para avaliar o risco de piora intra-hospitalar da IC e determinar a sua sensibilidade e especificidade em pacientes hospitalizados. Métodos O presente estudo de coorte foi realizado em um hospital universitário público brasileiro e os dados de 2013 a 2020 foram coletados retrospectivamente. Foram considerados estatisticamente significativos valores de p < 0,05. Resultados Foram incluídos 890 pacientes com idade média de 74 ± 8 anos. O modelo mostrou que no grupo de 490 pacientes de risco, 254 (51,8%) desenvolveram piora intra-hospitalar da IC. No grupo de 400 pacientes sem risco, apenas 109 (27,2%) apresentaram piora da IC. Os resultados demonstraram uma curva estatisticamente significativa (área sob a curva = 0,665; erro padrão = 0,018; p < 0,01; intervalo de confiança = 0,609 a 0,701), indicando boa precisão. O modelo apresentou sensibilidade de 69,9% e especificidade de 55,2%, com valor preditivo positivo de 52% e valor preditivo negativo de 72,7%. Conclusões Na presente coorte, demonstramos que o modelo de predição de risco ADHERE foi capaz de discriminar pacientes que, de fato, desenvolveram piora da IC durante o período de internação daqueles que não desenvolveram.

Abstract Background Patients admitted with acute decompensated heart failure (HF) are subject to developing worsening episodes that require more complex interventions. The Acute Decompensated Heart Failure National Registry (ADHERE) risk model was developed in the United States to predict the risk of in-hospital worsening HF. Objective To use the ADHERE risk model in the assessment of risk of in-hospital worsening HF and to determine its sensitivity and specificity in hospitalized patients. Methods This cohort study was conducted at a Brazilian public university hospital, and data from 2013 to 2020 were retrospectively collected. P values < 0.05 were considered statistically significant. Results A total of 890 patients with a mean age of 74 ± 8 years were included. The model showed that, in the group of 490 patients at risk, 254 (51.8%) developed in-hospital worsening HF. In the group of 400 patients not at risk, only 109 (27.2%) experienced worsening HF. The results demonstrated a statistically significant curve (area under the curve = 0.665; standard error = 0.018; P < 0.01; confidence interval = 0.609 to 0.701), indicating good accuracy. The model had a sensitivity of 69.9% and a specificity of 55.2%, with a positive predictive value of 52% and a negative predictive value of 72.7%. Conclusions In this cohort, we showed that the ADHERE risk model was able to discriminate patients who in fact developed worsening HF during the admission period, from those who did not.

Trombose: análise de conceito como subsídio teórico para qualificar a prática clínica de enfermeiros / Thrombosis: concept analysis as a theoretical contribution to qualify the clinical practice of nurses

OBJETIVO: analisar o conceito de trombose e identificar aplicações, atributos definidores, antecedentes, consequentes e referenciais empíricos. MÉTODO: análise de conceito, segundo Walker e Avant. RESULTADOS: os atributos definidores mais citados foram trombo (s), tríade de Virchow e comprometimento total/ parcial do fluxo sanguíneo. Os antecedentes mais frequentes foram câncer/uso de quimioterápicos, trombofilias e diabetes. Várias manifestações compuseram os consequentes, conforme o leito vascular comprometido. Os mais citados foram: acidente vascular cerebral ou acidente isquêmico transitório, infarto agudo do miocárdio e tromboembolismo pulmonar. Os referenciais empíricos se relacionaram a exames clínicos, testes de coagulação e escores de risco. A tomografia computadorizada foi o exame de imagem mais citado. CONCLUSÃO: a análise de conceito de trombose evidenciou o uso deste termo na literatura atual, bem como os atributos definidores, antecedentes, consequentes e referenciais empíricos. Este estudo agrega conhecimento à prática clínica de enfermeiros e pode contribuir com o refinamento dos sistemas de linguagens padronizadas.

OBJECTIVE: to analyze the concept of thrombosis and identify its applications, defining attributes, antecedents, consequences, and empirical references. METHOD: a concept analysis was carried out using Walker and Avant's framework. RESULTS: the most cited defining attributes were thrombus, Virchow's triad, and total/partial impairment of blood flow. The most frequent antecedents were cancer/chemotherapy, thrombophilia, and diabetes. Several manifestations composed the consequences, according to the compromised vascular bed. The most cited were stroke or transient ischemic attack, acute myocardial infarction, and pulmonary thromboembolism. The empirical references were related to clinical examinations, coagulation tests, and risk scores. Computed tomography was the most cited imaging test. CONCLUSION: The analysis of the thrombosis concept showed the use of this term in the current literature, its defining attributes, antecedents, consequences, and empirical references. This study adds knowledge to nurses' clinical practice and can contribute to the refinement of standardized language systems.

Development of a nursing outcome for a percutaneous procedure.

OBJECTIVES: To develop a nursing outcome, consistent with the standardized format of outcomes within the nursing Outcomes Classification (NOC). This outcome will include an outcome label, an outcome definition, and clinical indicators. The proposed use for this outcome is to evaluate the access site of a percutaneous procedure. METHODS: Concept analysis with a scoping review. Initially, content experts were recruited to validate the indicators of the proposed outcome in order to complete a consensus validation. After consensus validation, a review of the proposed outcome and its indicators was completed by two of the editors of the NOC team to confirm that the outcome label, definition, and indicators were consistent with the NOC taxonomy. During this review, edits were made on the label name and definition. FINDINGS: After a series of reviews, the initial outcome of Vascular Status: Percutaneous Procedure Access was changed to Tissue Injury Severity: Percutaneous Procedure. In addition, the original definition of the condition of an access site for percutaneous procedure by venous or arterial puncture and health of surrounding tissues was edited to: Severity of complications from a needle-puncture access through the skin and into deeper tissues. The outcome has 11 indicators to be used to formulate a target rating for use in the clinical setting. The indicators were not edited over the course of the reviews. CONCLUSION: The proposed outcome will assist nurses in evaluating the access site of percutaneous procedures and in identifying possible complications. IMPLICATIONS FOR THE NURSING PRACTICE: This research contributes to the refinement of the NOC taxonomy by having a new outcome that meets clinical practice needs.

OBJETIVOS: Desenvolver um resultado de enfermagem, consistente com o formato padronizado de resultados da Classificação dos Resultados de Enfermagem (NOC). Este resultado incluirá um título de resultado, uma definição de resultado e indicadores clínicos. O uso proposto para esse resultado é avaliar o local de acesso de um procedimento percutâneo. MÉTODOS: Análise de conceito com revisão de escopo. Inicialmente, especialistas de conteúdo foram utilizados para validar os indicadores do resultado proposto em uma validação por consenso. Após a validação por consenso, uma revisão do resultado proposto e de seus indicadores foi realizada por dois editores da equipe da Classificação dos Resultados de Enfermagem para confirmar o título do resultado, definição e indicadores para serem consistentes com a taxonomia NOC. Durante esta revisão, foram feitas edições no título e na definição. RESULTADOS: Após uma série de revisões, o resultado denominado inicialmente de Estado Vascular: Acesso Procedimento Percutâneo foi alterado para Gravidade da Lesão Tecidual: Procedimento Percutâneo. Além disso, a definição original de condição de um local de acesso de procedimento percutâneo por punção venosa ou arterial e saúde dos tecidos adjacentes foi editada para - Gravidade das complicações de um acesso por punção com agulha através da pele e em tecidos mais profundos. O resultado tem 11 indicadores a serem usados para formular uma classificação-alvo para uso no ambiente clínico. Os indicadores não foram editados ao longo das revisões. CONCLUSÃO: O resultado proposto auxiliará o enfermeiro a avaliar o local de acesso dos procedimentos percutâneos e identificar possíveis complicações. IMPLICAÇÕES PARA A PRÁTICA DE ENFERMAGEM: Esta pesquisa contribui para o refinamento da taxonomia NOC por ter um novo resultado que atende às necessidades da prática clínica.

Routine workflow in a reference clinical research center in face of COVID-19.

OBJECTIVE: To develop and validate the content of workflows for trial participants care in a clinical research center during the Covid-19 pandemic. METHOD: development study by consensus of experts carried out from March to July 2020 in southern Brazil. The flowcharts were developed following literature and validated by specialists considering comprehensiveness, clarity and pertinence, obtaining a 100% agreement index on each item of the developed instruments. The study was approved by the Ethics Committee of the institution. RESULTS: two flowcharts of care were elaborated and validated: "Flow diagram to conduct protocols with research participant " and "Flow diagram in protocols with research participant with suspected or confirmed COVID-19 infection"; which describes activities to ensure continuity of care. FINAL CONSIDERATIONS: a routine workflow can promote the continuity and safety of clinical research protocols. It is expected that the adopted flowcharts in this study can guide other institutions with a similar research profile.

Design of a multifaceted strategy based on automated text messaging in patients with recent heart failure admission.

AIMS: To evaluate a telemonitoring strategy based on automated text messaging and telephone support after heart failure (HF) hospitalization. METHODS AND RESULTS: The MESSAGE-HF study is a prospective multicentre, randomized, nationwide trial enrolling patients from 30 clinics in all regions of Brazil. HF patients with reduced left ventricular ejection fraction (<40%) and access to mobile phones are eligible after an acute decompensated HF hospitalization. Patients meeting eligibility criteria undergo an initial feasibility text messaging assessment and are randomized to usual care or telemonitoring intervention. All patients receive a HF booklet with basic information and recommendations about self-care. Patients in the intervention group receive four daily short text messages (educational and feedback) during the first 30 days of the protocol to optimize self-care; the feedback text messages from patients could trigger diuretic adjustments or a telephone call from the healthcare team. After 30 days, the frequency of text messages can be adjusted. Patients are followed up after 30, 90, and 180 days, with final status ascertained at 365 days by telephone. Our primary endpoint is the change in N-terminal pro-brain natriuretic peptide (NT-proBNP) levels after 180 days. Secondary endpoints include changes in NT-proBNP after 30 days; health-related quality of life, HF self-care, and knowledge scales after 30 and 180 days; and a composite outcome of HF hospitalization and cardiovascular death, adjudicated by a blinded and independent committee. CONCLUSIONS: The MESSAGE-HF trial is evaluating an educational and self-care promotion strategy involving a simple, intensive, and tailored telemonitoring system. If proven effective, it could be applied to a broader population worldwide.

Evaluation of percutaneous renal biopsy complications based on outcomes and indicators of the Nursing Outcomes Classification.

OBJECTIVE: to evaluate the complications of percutaneous renal biopsy based on outcomes and clinical indicators of the Nursing Outcomes Classification. METHOD: a prospective longitudinal study. The sample consisted of 13 patients submitted to percutaneous renal biopsy, with 65 evaluations. The patients were evaluated in five moments in the 24 hours after the procedure, using an instrument developed by the researchers based on five outcomes (Blood coagulation, Circulation status, Blood loss severity, Pain level, Comfort status: Physical) and 11 indicators. The Generalized Estimation Equation Test was used to compare the scores of the indicators. The project was approved by the institutional ethics committee. RESULTS: in the 65 evaluations, a statistically significant difference was identified in the reduction of the scores of the following nursing outcomes: Blood coagulation, "hematuria" indicator; Circulation status, in the "systolic blood pressure and diastolic blood pressure" indicators and Comfort status: physical, in the "physical well-being" indicator. CONCLUSION: the evaluated patients did not show major complications. The clinical indicators signaled changes in circulation status, with reduced blood pressure, as well as in blood clotting observed by hematuria, but without hemodynamic instability. The comfort status was affected by the rest time after the procedure.

Research care workflow in a reference clinical research center in face of Covid-19 / Diagramas de atención en un centro de referencia en investigación clínica frente a Covid-19 / Fluxogramas de atendimento em um centro de referência em pesquisa clínica frente a Covid-19

Objective: To develop and validate the content of care flowcharts in a Clinical Research Center during the Covid-19 pandemic.Method: development study by consensus of experts carried out from March to July/2020 in southern Brazil. The flowcharts were developed from the literature and validated by specialists considering comprehensiveness, clarity and pertinence, obtaining a 100% agreement index, on each item of the developed instruments. The study was approved by the Ethics Committee of the institution.Results: two flowcharts of care were elaborated and validated: General care to the research participant (without suspicion of Covid-19) and assistance to the research participant with suspicion or Covid-19 confirmed; which describe activities to ensure continuity of care. Conclusion: flowcharts can promote the continuity and security of research protocols. It is expected that the flows adopted can guide other institutions with a similar profile of care.

Objetivo: Desarrollar y validar el contenido de diagramas de flujo de atención en Centro de Investigación Clínica durante la pandemia de Covid-19.Método: Estudio de desarrollo por consenso de expertos realizado de marzo a julio / 2020 en el sur de Brasil. En el estudio participaron doce expertos de diferentes áreas. Los diagramas de flujo fueron desarrollados a partir de la literatura y validados por especialistas considerando la amplitud, claridad y pertinencia, obteniendo un índice de concordancia del 100%, en cada ítem de los instrumentos desarrollados. Estudio fue aprobado por el Comité de ética de la institución.Resultados: Se elaboraron y validaron dos diagramas de atención: Atención general al participante en la investigación (sin sospecha de Covid-19) y asistencia al participante en investigación con sospecha o Covid-19 confirmada; que describen actividades para asegurar la continuidad de la atención.Conclusión: Los diagramas de flujo pueden promover la continuidad y seguridad de los protocolos de investigación. Se espera que los flujos adoptados puedan guiar a otras instituciones con un perfil similar de atención.

Objetivo: Desenvolver e validar o conteúdo de fluxogramas de atendimento em Centro de Pesquisa Clínica durante a pandemia Covid-19 Método: Estudo de desenvolvimento e validação por consenso de especialistas realizado de março a julho/2020 no sul do Brasil. Participaram do estudo 12 especialistas de diferentes áreas. Os fluxogramas foram desenvolvidos a partir da literatura e validados por especialistas considerando abrangência, clareza e pertinência, obtendo-se índice de concordância de 100%, sobre cada item dos instrumentos desenvolvidos. Estudo aprovado no Comitê de Ética da instituição.Resultados: Construiu-se dois fluxogramas: "Atendimento geral ao participante de pesquisa (sem suspeita de Covid-19)" e "Atendimento ao participante de pesquisa com suspeita ou Covid-19 confirmado"; os quais descrevem atividades visando assegurar a continuidade do cuidado. Conclusão: os fluxogramas permitem que a continuidade e segurança dos protocolos de pesquisa sejam mantidos. Espera-se que os fluxos adotados possam nortear outras instituições com perfil semelhante de atendimento.

Prognostic Indicators of Delayed Surgical Recovery in Patients Undergoing Cardiac Surgery.

PURPOSE: The purpose of this study was to analyze the prognostic capacity of the clinical indicators of a delayed surgical recovery nursing diagnosis throughout the hospital stay of patients having cardiac surgery. DESIGN: A prospective cohort design was adopted. A sample of inpatients undergoing elective cardiac surgery was followed during the immediate preoperative period and hospitalization. This research was conducted in the southeast region of Brazil at a national reference institution that treats highly complex diseases and performs cardiac surgeries. Data were collected from July 2017 to July 2018. METHODS: At the end of 1 year of data collection, 181 patients were followed in this study. The Kaplan-Meier method was used to calculate the survival time related to delayed surgical recovery. In addition, an extended Cox model of time-dependent covariates was adjusted to identify the clinical signs that influenced the change in the nursing diagnosis status. RESULTS: A delayed surgical recovery nursing diagnosis was present in 23.2% of the sample studied. With an expected length of stay of 8 to 10 days, most new cases of delayed surgical recovery were observed on the 10th postoperative day, and the survival rate after this day was decreased until the 29th postoperative day, when the nursing diagnosis no longer appeared. Interrupted healing of the surgical area, loss of appetite, and atrial flutter were indicators related to an increased risk for delayed surgical recovery. CONCLUSIONS: Timely recognition of selected clinical indicators demonstrates a promising prognostic capacity for delayed surgical recovery. CLINICAL RELEVANCE: Accurate identification of prognostic factors allows nurses to identify early signs of postoperative complications. Consequently, the professional can develop an individualized plan of care, aiming at the satisfactory clinical recovery of the patient.